Catalog Number

79SOFT-25

Brand Name

N/A

Version/Model Number

79SOFT-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113542,K113542

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

69cdbb98-ce8a-498f-8b3e-194886ad8bf8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10607411915953

Quantity per Package

10

Contains DI Package

00607411915956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-